Methods and devices for manipulating and fastening tissue

ABSTRACT

A tissue displacing and fastening device is provided for manipulating and fastening tissue together. The device includes a tissue displacing elements, which displaces tissue. A fold is formed from the displaced tissue and the tissue is fastened together to secure the fold.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is related to application Ser. No. ______, filedSep. 9, 2011, and to application Ser. No. ______ filed Sep. 9, 2011,both by Richard Romley, which are both hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates to methods and devices for manipulatingand fastening tissue. In particular, the present invention may be usefulin treating gastroesophageal reflux disease (GERD).

Referring to FIG. 2, a normal stomach and esophagus are shown with adisease state shown in the dotted line position. GERD develops in thedisease state since the gastroesophageal flap valve at the junction orintersection between the esophagus and stomach has deteriorated so thatstomach contents can splash into the esophageal tract resulting in GERD.The disease state is associated with a shorter esophageal tract and asomewhat enlarged stomach. The junction has also moved orally therebyeffectively shortening the esophageal tract as well.

SUMMARY OF THE INVENTION

The present invention provides devices and methods for manipulating andfastening tissue together. The device includes numerous aspects, whichmay be practiced by themselves or in combination with other aspects ofthe invention. The device will be described in connection with treatingGERD but shall have applications in other fields as well.

The device includes a shaft and a tissue displacing element coupled tothe shaft. The tissue displacing element is configured to reshapestomach tissue. The stomach tissue is then fastened together to form afold. When treating GERD the fold is formed at the intersection of theesophageal tract and stomach.

In one aspect of the invention, a plurality of tissue displacingelements are coupled to the shaft. The displacing elements arepreferably individually and independently movable. The device may alsoinclude a common retractor, which is configured to displace the tissuedisplacing elements simultaneously. When used to recreate the junctionbetween the esophagus and stomach, the common retractor may be moveddistally along the shaft to lengthen the fold of tissue. The device mayinclude a lock, which couples two tissue displacing elements togetherwhile maintaining the ability to independently move, or maintainstationary, the third element. In this manner, two of the tissuedisplacing elements may be simultaneously moved while at least onetissue displacing element remains stationary.

The tissue displacing element may include an elongate element, such as awire, having an engaging element, such as a helical coil, at the distalend. Once the coil is rotated into tissue, the tissue is displaced byapplying tension to the wire. The wire may have a curved distal portionso that rotation of the wire changes a position and angular orientationof the wire. A sheath may be slidable over the wire to cover and uncoverthe distal portion of the wire. The shape of the distal portion changeswhen the sheath covers and uncovers the wire thereby providing greaterflexibility in directing the coil to engage a particular stomachlocation.

In another aspect of the invention, the device may include a tissueshaper coupled to the shaft. Tissue may be moved into the tissue shaperby simply moving the tissue displacing element to draw tissue into thetissue shaper. Alternatively, tissue may be moved into the tissue shaperby moving only the tissue shaper or the tissue shaper and the tissuedisplacing element simultaneously. The shaper has a cavity with an openproximal end leading to the cavity. The tissue displacing element may bemovable within the cavity and to positions proximal and distal to thecavity. The tissue shaper may also be removable from the shaft andreplaceable with another shaper. The shaft may include a primary shaftand a secondary shaft, which are slidable relative to one another, thetissue shaper being coupled to the primary shaft and the tissuedisplacing element being coupled to the secondary shaft.

The tissue shaper may also be partially or completely resilient so thatthe cavity may be expanded and to provide compression on tissue astissue enters the cavity. The elastomeric portion may be positioned atthe proximal open end of the cavity so that the proximal end may expandto accommodate tissue. The cavity may also include an elastomericportion adjacent a midportion of the cavity. The flexibility of thetissue shaper may also be enhanced by providing a plurality oflongitudinal slits in the tissue shaper. The device may also include atension sensor coupled to the tissue displacing element. The tensionsensor measures tension on the tissue displacing element developedduring displacement of tissue.

The shaft may include a vacuum orifice configured to adhere the shaft totissue. The vacuum orifice may be used to grasp the esophageal tract.The vacuum orifice may be used to stabilize tissue displaced by thetissue displacing element so that the tissue displacing element may bereleased and repositioned to displace another part of the stomach whilethe vacuum orifice holds previously displaced stomach tissue.

The device may also include a tissue shifting element configured toshift tissue held by the shaper. The tissue shifting element may beconfigured to engage a stomach side of the fold and displace the stomachside of the fold distally thereby moving the intersection of the folddistally. Alternatively, the tissue shifting element may displace bothtissue layers such as the esophageal side and the stomach side whentreating GERD. The tissue shifting element displaces tissue to increasea length of the fold of tissue while the fold of tissue is positioned inthe cavity. The tissue shifting element may also draw tissue into theshaper while shifting tissue already held by the shaper.

The device may include a fastener applier which is a separate devicedelivered down a fastener lumen in the shaft. The fastener applier mayinclude a fastener cartridge containing a plurality of fasteners and maydeliver a plurality of fasteners in a single actuation. The fastenercartridge may apply a compressive force to the fold of tissue prior toapplication of the fastener.

The common retractor may include a slot in which the tissue displacingelement is positioned so that the central axis of the wire translateswithin the slot. Movement within the slot changes an angular position byat least 45 degrees with respect to the longitudinal axis of the shaftwhen moving within the slot. The change in angular position provided bythe slot may be accomplished without moving the shaft.

These and other features and aspects of the invention will becomeapparent from the following description of the preferred embodiment,drawings and claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows a device for manipulating and fastening tissue of thepresent invention.

FIG. 2 shows a stomach and an outline of the stomach in a disease state.

FIG. 3 shows the device inserted into the stomach and a tissue engagingelement extended to engage stomach tissue.

FIG. 4 shows a perspective view of the device.

FIG. 5 is a cross-sectional view of the device at line A-A of FIG. 4.

FIG. 6 is a cross-sectional view of the device of FIG. 5 with guidetubes moved within slots to translate the tissue displacing elements.

FIG. 7 shows the range of motion provided by the tissue displacingelement and the range of motion provided when the sheath is used.

FIG. 8 shows a tissue shifting element in a stored position.

FIG. 9 shows the tissue shifting element engaging one tissue layer ofthe tissue fold.

FIG. 10 shows the tissue shifting element engaging both tissue layers ofthe tissue fold.

FIG. 11 shows a fastener applier, which may be used with the presentinvention.

FIG. 12 shows another fastener applier.

FIG. 13A shows another fastener applier prior to delivery of thefastener.

FIG. 13B shows the fastener of FIG. 13A delivered into the tissue fold.

FIG. 14 shows still another fastener applier.

FIG. 15 shows the device delivered into the stomach and positioned in adesired location to recreate the intersection between the stomach andesophageal tract.

FIG. 16 shows a second tissue displacing element engaging stomachtissue.

FIG. 17 shows the first and third tissue displacing elements engagingstomach tissue after retracting stomach tissue with the second tissuedisplacing element.

FIG. 18 shows the first and third tissue displacing elements retractingstomach tissue after engagement with tissue in FIG. 17.

FIG. 19 shows the second tissue displacing element disengaged fromstomach tissue, reengaged with stomach tissue and retracted again whilethe first and third tissue displacing elements maintain the tissue fold.

FIG. 20 shows all three tissue displacing elements engaged with tissueand positioned proximate a common retractor.

FIG. 21 shows all three tissue displacing elements engaged with tissueand retracted to the common retractor.

FIG. 22 shows three tissue displacing elements simultaneously displacedinto the tissue shaper using the common retractor.

FIG. 23 shows all three tissue displacing elements retracted further bythe common retractor.

FIG. 24 shows fasteners applied to the stomach to create a tissue foldin accordance with the present invention.

FIG. 25 show another view of the stomach where additional fasteners havebeen applied to the tissue fold.

FIG. 26 shows the tissue displacing element engaged with stomach tissue.

FIG. 27 shows the tissue displacing element retracted to displace tissuetoward the tissue shaper.

FIG. 28A shows the tissue displacing element moved within the slot todisplace tissue toward an end of the tissue shaper.

FIG. 28B shows the tissue displacing element of FIG. 28A moved into thetissue shaper.

FIG. 29 shows the second tissue displacing element engaged with tissueafter displacement in accordance with FIGS. 26, 27, 28A and 28B

FIG. 30 shows the second tissue displacing element moving tissue withthe first and third tissue displacing elements prior to displacementtowards the ends of the shaper.

FIG. 31 shows tissue extending through an open distal end of the shaperfor manipulation by the tissue displacing elements.

FIG. 32 shows the device with a removable tissue shaper attached to theshaft.

FIG. 33 shows the device with another tissue shaper attached to theshaft.

FIG. 34 shows the device with still another tissue shaper attached tothe shaft.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1, 4 and 5, a device 2 for manipulating and fasteningtissue is shown. The device 2 and various aspects thereof may be used tomanipulate and fasten tissue anywhere in the body. In particular, thedevice 2 of the present invention may be used to manipulate stomachtissue to recreate the intersection between the stomach and theesophageal tract.

The device 2 includes a tissue shaper 4 which shapes tissue into adesired shape such as a gastroesophageal flap valve. The device 2 hasfirst, second and third tissue displacing elements 6, 8, 10 which gatherand manipulate tissue into a cavity 50 in the tissue shaper 4. Thetissue displacing elements 6, 8, 10 are coupled to a common retractor 12having a platform 14 which may be used to simultaneously move the tissuedisplacing elements 6, 8, 10 as described below. The tissue shaper 4 iscoupled to a shaft 15 consisting of a flexible primary shaft 16 and aflexible secondary shaft 22 and may be releasably coupled to the shaft15 as described below. The shaft 15 defines a longitudinal axis 18 andangular orientations and displacements are often defined and describedherein as being relative to the longitudinal axis 18. For example,referring to FIG. 6, an angle B is defined between the first and secondtissue displacing elements 6, 8 as defined relative to the longitudinalaxis 18. The longitudinal axis 18 may be substantially straight or maybe curved without departing from the scope of the invention so long asthe longitudinal axis 18 generally follows and defines the orientationof the shaft 15. The primary shaft 16 terminates at the proximal end ata lock 20 which locks and seals the primary shaft 16 to the secondaryshaft 22. When the lock 20 is unlocked, the primary and secondary shafts16, 22 may be moved relative to one another. The primary and secondaryshafts 16, 22 are movable relative to one another so that the commonretractor 12 and platform 14 are movable as shown by the solid anddotted line positions of FIG. 1 although the common retractor 12 hasgreater range of motion than depicted in both directions. A plurality ofvacuum orifices 23 are positioned on the primary shaft 16 to grasptissue, such as the esophageal tract, as also described below. Thevacuum orifices 23 are coupled to a suction source 25 through a spacebetween the first and second shafts 16, 22.

The tissue shaper 4 forms a fold of tissue which is substantiallysimilar to a natural gastroesophageal flap valve. To this end, thetissue shaper 4 forms a generally tubular structure open on both ends,the esophagus on one side and the stomach on the other. The generallytubular structure may also have an open side proximate the esophagus ormay be a substantially closed shape. Referring to FIGS. 5 and 6, thetissue shaper 4 has a generally curved cross-sectional shape terminatingat a first end 24 and a second end 26. The curved cross-sectional shapeforms an arc of at least 180 degrees relative to the longitudinal axisbetween the first and second ends 24, 26. The tissue shaper 4 alsodefines a central plane 28 (FIG. 6) which lies equidistant from thefirst and second ends 24, 26 and/or may define an axis of symmetry whenviewed along the longitudinal axis 18. The second tissue displacingelement 8 lies on the central plane 28 but may be offset from the plane28 as well.

The tissue shaper 4 may, of course, take other suitable cross-sectionalshapes such as oval, round, or V-shaped without departing from the scopeof the invention and it is understood that these shapes also would havea central plane as defined herein. Furthermore, the tissue shaper 4 mayalso be omitted without departing from various aspects of the presentinvention. For example, the tissue displacing elements 6, 8, 10 alonemay be used to displace stomach tissue and form a fold of tissue bysimply displacing the tissue in a manner which forms the fold of tissuewithout requiring the tissue shaper 4. The tissue may be displaced intothe shaper 4 without moving the shaper 4 and using only elements 6, 810, moving only the tissue shaper 4, or moving both the elements 6, 8,10 and shaper together.

Referring to FIG. 7, the tissue displacing elements 6, 8, 10 eachinclude a tissue engaging element 30, such as a helical coil 32, whichis rotated to pierce and engage tissue as is known in the art. The coil32 is coupled to an elongate element 34, such as a wire 35, and theelongate element 34 is covered by a retractable sheath 36. The elongateelement 34 may have a curved shape which permits the user to direct thedistal end in a desired direction by simply rotating element 30. Thesheath 36 may be advanced over the wire 35 to change the shape of thedistal portion to provide a broader range of motion to direct the coil32 as desired. FIG. 7 shows the elongate element 34 bent further by thesheath 36, however, the sheath 36 could also straighten the elongateelement 34. Furthermore, the elongate element 34 or sheath 36 may besubstantially straight, rather than bent, without departing from thescope of the invention.

As will be described further below, the tissue engaging elements 6, 8,10 may be used to displace tissue substantially longitudinally when thewire 35 is retracted. The elements 6, 8, 10 may be retracted into andextended from the shaft as shown throughout the Figures. The curvedshape of the wire 35 may also provide an angular displacement (change inorientation) with respect to the longitudinal axis 18 of at least 45degrees when the element 6, 8, 10 is retracted. Stated another way, theelements 6, 8, 10 may apply an angular displacement of at least 45degrees relative to the ends 24, 26 of the tissue shaper 4 (in additionto longitudinal displacement) when the wire 35 is retracted. This aspectof the invention will be described in greater detail below. The angulardisplacements or change in angular orientation is accompanied bylongitudinal displacement toward the patient's feet and into the stomachof at least 5 cm and is typically 2 to 6 cm.

Once the helical coil 32 has engaged tissue as shown in FIG. 3, tensionis applied to the elongate element 34 to move the stomach tissue towardthe tissue shaper 4. The elongate element 34 may be coupled to a tensionsensing element, such as a simple spring element 41 shown in dotted linewith only element 8, which displays an indication of tension on theelongate element at an indicator 40. Use of the tension indicators 40 isdescribed below in connection with use of the device 2. The tissueengaging element 6, 8, 10 may grip tissue using any other suitablemethod including graspers or a suction gripper without departing fromthe scope of the invention. A twist lock 42 is provided to lock each ofthe tissue displacing elements 6, 8, 10 at any suitable positionrelative to the secondary shaft 22 and maintain tension on the elongateelements 34.

Referring to FIG. 16, in one aspect of the present invention, one of thetissue displacing elements 6, 8, 10, such as the second tissuedisplacing element 8, may be displaced until a threshold tension isreached at which time the user applies the appropriate lock 42 (seeFIG. 1) to lock the tissue displacing element 8 as shown in FIG. 17. Asalso shown in FIG. 17, the user may manipulate another of the elements6, 10 until another threshold tension or displacement is reached atwhich time the user again applies the appropriate lock 42 as shown inFIG. 18. The second tissue displacing element 8 may then be disengaged,moved, reengaged with tissue and retracted again as shown in FIG. 19. Inthis manner, the user may continue to individually displace each of thetissue displacing elements 6, 8, 10, while maintaining engagement withthe other elements until the desired shape is achieved. The tensionindicators 40 may be used with any method described herein even when notexpressly described.

The first and third tissue displacing elements 6, 10 are also movablewithin elongate slots 44 in the platform between the position of FIG. 5near the ends 24, 26 of the shaper 4 to the position of FIG. 6 closer tothe second element 8. The sheath 36 and elongate element 34 arepositioned in guide tubes 46 which are movable in the slots 44 bymanipulating pull wires 48. The pull wires 48 are coupled to an actuator50, such as a control knob 51, which is simply rotated to move both pullwires 48 thereby moving the guide tube 46 within the slot 44. A lockingbutton 53 is provided to lock each of the control knobs 51 to fix theposition of the pull wires 48 and therefore fix the position of theguide tube 46 anywhere along the slot 44.

The slot 44 permits the tissue displacing element 6, 10 to be moved sothat a central axis 56 of the elongate element 34 is displaced at least45 degrees relative to the longitudinal axis 18 when viewed along thelongitudinal axis 18 as shown in FIG. 6 and represented by angle C.Stated another way, a portion 35 (FIG. 1) of the elongate element 34positioned at the slot 44 which emerges from shaft 15 changes angularposition by at least 45 degrees with respect to the longitudinal axis18. Movement in this manner is typically not possible with conventionalmulti-link arms and graspers which have a base which may pivot but isfixed in translation relative to the shaft.

The slots 44 may also lie generally on a plane defined by the platform14 which is substantially perpendicular to the longitudinal axis 18 ofthe primary shaft 16. Stated still another way, the slots 44 permit thetissue displacing elements 6, 8, 10 to change an angle B formed betweeneach of the first and third tissue displacing elements 6, 10 and thesecond tissue displacing element 8, or the central plane 28, by at least45 degrees relative to the longitudinal axis 18. In this manner, theslots 44 may be used to displace tissue toward and away from the ends24, 26 of the tissue shaper 4. The elongate element 34 may be retractedinto the guide tube 46 so that the helical coil 30 is positioned at theslot 44 (see FIGS. 27 and 28). When the coil 30 is positioned at theslot 44, translation of the coil 30 in the slot 44 shifts tissue withoutlongitudinal displacement which is useful in various methods describedbelow.

The tissue shaper 4 of FIG. 4 is configured to shape a fold of tissue torecreate a gastroesophageal flap valve. The tissue shaper 4 has a cavity50 which receives the tissue. As mentioned above, the tissue can bemoved into the cavity 50 by moving the elements 6, 8, 10 or shaper 4alone or by moving the shaper 4 and elements 6, 8, 10 together.

Referring to FIG. 4, the tissue shaper 4 may include an elastomericportion 52 on a proximal portion 54 of the tissue shaper 4 which permitsthe cavity 50 to expand to accommodate tissue. The elastomeric material52 is positioned at a proximal opening 56 of the cavity 50 so that theopening 56 can elastically expand thereby facilitating introduction of alarger tissue volume while applying a modest compressive force to tissueat the opening 56. The tissue shaper 4 will also increase compression ontissue contained in the cavity 50 as the tissue volume increases. Thetissue shaper 4 has an outer wall 58 which may have a plurality of slits60 formed therein to further increase the flexibility of the tissueshaper 4 and permit expansion of the cavity 50. The slits 60 extend fromthe proximal end 62 and extend toward a distal end 64 of the tissueshaper 4. The distal end 64 of the tissue shaper 4 also has a distalopening 65 to permit the tissue to extend through the tissue shaper 4 asdescribed below in connection with use of the device 2. The tissueshaper 4 may be a substantially fixed structure except for theelastomeric portion 52, however, the elastomeric portion 52 does providesome movability to the tissue shaper 4 in that the cavity 50 has a firstvolume during introduction which is less than a volume of the cavity 50when tissue is introduced into the expandable cavity 50. As such, thetissue shaper 4 does change shape even though the tissue shaper 4 is notmovable by the user. Although the tissue shaper 4 is shown as astructure, which is not moved by the user, the tissue shaper 4 may bemovable by the user to close the tissue shaper 4 (not shown) around thefold of tissue without departing from numerous aspects of the presentinvention.

Referring now to FIG. 32, a removable tissue shaper 4A is attached to aprimary shaft 16A. The tissue shaper 4A may be removably attached to theshaft 15 in any suitable manner such as a simple snap-fit connection 117or bayonette connection (not shown). Referring to FIGS. 33 and 34, twomore tissue shapers 4B, 4C are shown with the tissue shapers 4A, 4B, 4Cbeing interchangeable and usable in any manner that tissue shaper 4 isused. The user may decide upon which tissue shaper 4A, 4B, 4C to useprior to beginning the procedure and attach the appropriate tissueshaper 4A, 4B, 4C to the shaft 16A. Alternatively, the user may beginthe procedure with one of the tissue shapers 4A, 4B, 4C and may decideto change to another shaper (different shape and/or size). The presentinvention provides the ability to change shapers 4A, 4B, 4C or selectthe appropriate shaper 4A, 4B, 4C from available shapes and sizes.

The tissue shaper 4, 4A may have substantially straight edges, formingan acute angle, symmetrically disposed about the longitudinal axis 18(see FIG. 1 and FIG. 16). Alternatively, the profile edges could beconvex or concave, or any combination of concave, convex or straightedged profiles as now discussed in connection with tissue shapers 4B, 4Cof FIGS. 33 and 34. Referring to FIG. 33, for example, tissue shaper 4Bhas a convex outer wall 55B which creates a cavity 50B also having aconvex outer wall 57B. A proximal opening 56B leading to the cavity 50Bhas a smaller cross-sectional shape than a midportion 59B of the cavity50B. In this manner, the cavity 50B may be sized to hold the fold oftissue more loosely in the midportion 59B so that the tissue in themidportion 59B may be manipulated more easily within the cavity 50Bwhile the tissue fold is still being firmly held by the proximal opening56B. Use of elastomeric portion 52B may be particularly advantageous inholding tissue firmly at the proximal opening 56B.

Referring to FIG. 34, tissue shaper 4C has a concave outer wall 55C anda cavity 50C having a concave outer wall 57C. The cavity 50C has aproximal opening 56C, a distal opening 65C and a midportion 59C. Themidportion 59C has the smallest cross-sectional shape throughout thecavity 50C so that tissue contained in the cavity 50C may be held morefirmly by the midportion 59C. An elastomeric portion 52C of the shaper4C may be adjacent the midportion 59C which provides the advantagesdescribed above in connection with tissue shaper 4. Holding tissuewithin the shaper 4C in this manner may facilitate gathering tissueusing various methods described herein. For example, the tissue shaper4C may hold the fold of tissue firmly at the midportion 59C so thattissue near the distal opening 65C and extending through the distalopening 65C may be manipulated.

The tissue shaper 4C also includes a first clamping element 61 and asecond clamping element 63 (shown in dotted-line position). The firstand second clamping elements 61, 63 may be elastic balloons 75 but maybe any other suitable mechanism such as a pivoting jaw. FIG. 34 showsthe balloons 75 partially inflated to clamp tissue contained in thetissue shaper 4C. The first clamping element 61 is positioned near thedistal end and the second clamping element 63 is positioned along themidsection although any number of clamping elements (including only one)may be used. An inflation lumen 79 is coupled to the balloons 75 andextends through the connector 117 but may be a separate lumen as well.It is understood that the clamping elements 61, 63 may be incorporatedinto any of the other tissue shapers 4, 4A, 4B and use of the clampingelements 61, 63 with the any of the other tissue shapers 4, 4A, 4B isexpressly incorporated here.

The clamping element 61, 63 may be used to hold tissue contained withinthe tissue shaper 4C and may be clamped and unclamped as desired. Assuch, the balloons 75 may be deflated during the tissue displacing stepsand inflated to hold tissue after the displacing step. Thus, all methodsdescribed herein may include deflating the balloon 75 prior todisplacing tissue and/or may include inflating the balloon 75 after eachdisplacing step. The clamping elements 61, 63 may also be used to holdtissue during application of fasteners and, to this end, each methoddescribed herein may include the step of clamping the tissue foldtogether before fastening the fold together. The clamping element 61, 63may be released and again reapplied before each fastening step asdesired and, again, all methods described herein shall expressly providefor the clamping steps described herein.

As mentioned above, the common retractor 12 and platform 14 are coupledto the secondary shaft 22 so that the platform 14 may be moved relativeto the shaper 4. Movement of the secondary shaft 22 and the platform 14also moves all three of the tissue displacing elements 6, 8, 10simultaneously. The secondary shaft 22 includes lumens 66 which receivethe tissue displacing elements 6, 8, 10 and pull wire lumens 68 whichreceive the pull wires 44 for the guide tubes 46 (FIGS. 5 and 6). Asuction lumen 70 may also be provided which is coupled to vacuumorifices 72 in the platform 14. The vacuum orifices 72 and vacuumorifices 23 in the primary shaft 16 are coupled to a suction source 71as shown in FIG. 1 and are independently controllable as is known in theart.

A visualization lumen 74 is formed between the primary and secondaryshafts 16, 22 in which a visualization device 76 may be positioned. Thevisualization device 76 may be any suitable device and suitable devicesare described in U.S. Pat. No. 7,583,872, Compact Scanning Fiber Deviceand U.S. Pat. No. 6,275,255, Reduced Area Imaging Devices. In one aspectof the present invention, the lumen 74 which receives the visualizationdevice 76 is no more than 10% of a total cross-sectional area of theshaft 15. In one embodiment, the visualization lumen 74 may have adiameter of about 5 mm and the primary shaft 16 has a cross-sectionalarea of about 255 mm2. A lock 75 is also provided to couple movement ofthe first and third tissue displacing elements 6, 10 together asdescribed below in connection with various methods of the presentinvention.

The tissue, or parts, thereof, may be stabilized or engaged within thetissue shaper 4, or even outside the tissue shaper 4, using the tissuedisplacing elements 6, 8, 10, the vacuum orifices 72 in the platform 14or the vacuum orifices 23 on the primary shaft 16. Furthermore, it isunderstood that stabilizing tissue between tissue manipulations orfastening steps with any one of these elements may be practiced with anyof the methods described herein even if not specifically described. Forexample, some methods of the present invention describe stabilizingtissue with the second tissue displacing element 8 while moving tissuewith the first and/or third tissue displacing elements 6, 10 and suchmethods may be practiced by stabilizing tissue with any other suitableelement such as the vacuum orifices 23 on the primary shaft 16 or vacuumorifices 72 in the platform 14 and such methods are expressly includedas part of the invention.

The tissue shaper 4 may be sized to firmly hold the fold of tissue oncethe fold of tissue has been drawn into the cavity 50 while stillpermitting some movement of the tissue within the tissue shaper 4.Shifting tissue within the tissue shaper 4, as used herein, shall meanthat the tissue shaper 4 holds the fold of tissue so that at least partof the tissue is approximated and in contact with one another prior tofastening but are still held loosely enough to shift tissue within thetissue shaper 4 and/or draw tissue into the tissue shaper 4.

Referring to FIGS. 8-10, one structure which may be used to move orshift tissue within the tissue shaper 4 is a tissue shifting element110. The tissue shifting element 110 is coupled to the tissue shaper 4and provides a mechanism for shifting tissue within the tissue shaper 4without moving the tissue shaper 4 and preferably without moving theprimary or secondary shafts 16, 22. The tissue shifting element 110includes a pair of needles 112 mounted on a wire 114. The needles 112may be coupled to the wire in any suitable manner; for example, theneedles may pivotally engage the wire 114 or may have an integrallyformed hinge with the wire 11. The device 2 may include two sets ofneedles 112. One set of needles 112A may pierce one tissue layer (FIG.9) and the other set of needles 112 may penetrate both layers of thetissue fold (FIG. 10). Each wire 114 extends through a tube 116 havingan open slit 118 through which the needles 112, 112A extend. When thewire 114 is advanced to the position of FIG. 8, the needles 112 arecollapsed within the tube 116. When the wire 114 is moved proximally,the needles 112 naturally expand outwardly through the slit 118 andfurther proximal motion causes the needles 112, 112A to penetrate one orboth tissue layers. The tissue shifting element 110 may engage thetissue with any other suitable mechanism including a movable suctionport. Tissue may also be shifted within the tissue shaper 4 usingelements 6, 8, 10 which may apply longitudinal and/or angulardisplacements as described herein. For example, the elements 6, 8, 10may displace tissue further into the cavity 50 and displace tissuetowards or away from the ends 24, 26 of the shaper 4 by moving theelements 6, 10 within slots 44. As such, the displacing elements 6, 8,10 may also constitute tissue shifting elements for shifting tissuewithin the tissue shaper 4 as used herein. The tissue shifting element110 is omitted for clarity in various drawings but all drawingsincluding the tissue shaper 4 shall be interpreted to include the tissueshifting element 110.

Any suitable fastener may be used with the present invention and, infact, numerous aspects of the present invention may be practiced withany other suitable fastening method such as adhesive or suture. Severalsuitable fastener appliers are described below in connection with FIGS.11-14. Although the fastener applier is a separate device delivered downthe fastener lumen 74, numerous aspects of the present invention may bepracticed with the fastener applier being integrated into the device 2rather than being a separate device. An advantage of providing aseparate fastener applier is that the device 2 may be advanced down thepatient's esophagus without the fastener applier positioned in thefastener lumen 74 which may provide a more flexible device forintroduction than would a device having the fastener applier integratedinto the device 2. The fastener lumen 78 includes a window 80 in theprimary shaft 16 so that the fastener may be applied anywhere along anarc of at least 90 degrees, and may be at least 120 degrees, relative tothe longitudinal axis 18 without moving the shaft 15 or the tissueshaper 4. The fastener lumen 74 may also include a ramp 80 which causesthe fastener applier to be displaced radially outward from thelongitudinal axis 18 to compress the fold of tissue prior to delivery ofthe fastener as described below and shown in FIG. 12.

Referring now to FIG. 11, a fastener applier 90 is shown. The fastenerapplier 90 includes a cartridge 92 containing a plurality of fastenerssuch as staples 94. An actuator 96 is coupled to a firing mechanismwhich is actuated to deploy the fasteners in any suitable fashion as isknown in the art. The fastener applier 90 may be configured to deliver aplurality of staples 94 simultaneously and, in particular, in alongitudinal orientation. Different cartridges 92A, 92B may be providedto dispense a different number or orientation of staples 94 as desiredand methods of the present invention may provide for sequential use ofthe cartridges 92, 92A, 92B. The fastener applier 90 may also belongitudinally movable with respect to the tissue shaper 4 and theprimary shaft 16 so that the fastener applier 90 may be used atdifferent longitudinal positions without moving the primary shaft 16and/or the tissue shaper 4. Numerous aspects of the present inventionmay be carried out with the tissue fold being fastened in any suitablemanner including use of an adhesive or conventional suture rather thandiscrete fasteners. Additional aspects of the fastener applier 90 aredescribed in connection with use of the device.

Another fastener applier 96 is shown in FIG. 12. The fastener applier 96contains a helical fastener 98 which is rotated into engagement withtissue using an actuator 99. The fastener applier 96 has an open distalend 100 which is directed toward the tissue by the ramp 80 to furthercompress the tissue fold prior to application of the fastener 98. Thehelical fastener 98 is rotated and advanced with the actuator 99 so thata sharp tip 102 penetrates and advances into the tissue fold. Afterapplication of the helical fastener 98, another fastener applier 96 isused or another fastener 98 is delivered down the same applier 96.

Referring to FIGS. 13A and 13B, yet another fastener applier 101 isshown which delivers a helical fastener 103. The fastener 103 has asharp tip 113 and form a number of coils 115 which define an axis 117.The fastener 103 is oriented longitudinally within a shaft 105 of theapplier but is deployed in a manner which reorients the axis 117 upondeployment. An actuator 107 rotates and advances the helical fastener103 which causes the helical fastener 103 to contact a deflectingelement 109 which deflects the fastener 103 outwardly from the shaft 105and into tissue. As the helical fastener 103 is deployed, the deflectingelement 109 causes the axis 117 to be displaced at least 45 degrees fromthe stored position within the shaft to the deployed position outsidethe shaft 105.

Referring to FIG. 14, still another fastener applier 121 is shown whichdelivers a plurality of helical fasteners 123. The fasteners can bedelivered sequentially or simultaneously. The helical fasteners 123forms a plurality of coils 129 which define an axis 131 and a lengthmeasured along the axis 131. The helical fasteners 123 are deployedthrough one or more side openings 125 upon movement of a rack 127 thatrotates a gear 135 coupled to the fasteners 123 so that simplelongitudinal motion of the rack 127 rotates all of the fastenerssimultaneously. The fasteners 123 may be compressed in a stored positionwithin the shaft 125 so that a natural unbiased length of the fastener123 is at least 1.5 times, or even 2.0 times, a stored length (orcompressed length) SL of the fasteners 123 within the shaft. As thefastener 123 is deployed, the fastener 123 naturally expands toward thenatural unbiased length. In another aspect, the opening 125 may beoriented to direct the fastener 123 into an even larger length than theunbiased length by simply applying a greater pitch upon delivery throughthe opening. In this manner, the coils 129 are initially expanded sothat tissue between the coils is compressed as the fastener 123 isdeployed. For example, the fastener applier 121 may be configured todeploy the fastener 123 at a deployed length DL which is 2.5 times thestored length SL while the relaxed or unbiased length is 2.0 timeslarger than the stored or compressed length SL.

Methods of using the device 2 are now described. As will be appreciated,the present invention provides great flexibility in the manner in whichthe fold of tissue is formed and fastened together. As such, all methodsof forming the fold shall be applicable to all methods of fastening thetissue together and such combinations are expressly included as part ofthe present invention even if not expressly described. Furthermore, allmethods of manipulating tissue which are described in connection withmoving tissue within or into the tissue shaper 4 may be practicedwithout the tissue shaper 4 or below the tissue shaper 4 and all suchmethods are expressly incorporated herein.

The device 2 is delivered down a patient's esophagus into the positionof FIG. 15 so that the tissue shaper 4 is distal to the existingintersection between the esophageal tract and the stomach associatedwith a disease state. The visualization device 76 is used to view thestomach and orient the tissue shaper 4 within the stomach so that thetissue shaper 4 is positioned to create the fold of tissue in thedesired position. An advantage of the present invention is that the usermay not need to reposition the tissue shaper 4 once the desired positionhas been chosen. Of course, numerous aspects of the present inventionmay be practiced while moving the tissue shaper 4 between differentpositions without departing from the scope of the invention. Forexample, the tissue shaper 4 could be used to gather and fasten tissueinto a fold and could be rotated to another position to create anotherfold.

At least one of the tissue displacing elements 6, 8, 10, such as thesecond tissue displacing element 8, is then extended outwardly to engagestomach tissue as shown in FIG. 3. The sheath 36 may be extended tocover the wire 35 to change the shape of the wire 35 to provide adifferent shape to facilitate engaging the desired stomach tissuelocation (see FIG. 7). The coil 32 is then rotated to engage the stomachtissue. Referring to FIGS. 1, 3 and 16, the second tissue displacingelement 8 may then be pulled to draw stomach tissue toward the tissueshaper 4 which increases tension on the elongate element 34 andregisters at the tension indicator 40. The user may refer to the tensionindicator 40 to assist in assessing formation of the fold and the forceswhich may be required to maintain the fold. The user may retract thetissue displacing element 8 until a threshold tension is reached atwhich time the lock 42 is applied to maintain tension as shown in FIG.17. The user may then engage stomach tissue with another of the elements6, 10, such as the first element 6, and retract tissue until anotherthreshold tension is reached, or desired displacement is achieved, andthe appropriate lock 42 is applied as shown in FIG. 18. This process maybe repeated until the stomach tissue has been displaced a desired amountby each of the tissue displacing elements 6, 8, 10 (see FIGS. 19 and20).

An advantage of the present invention is that a stepwise displacement oftissue is possible since the plurality of elements 6, 8, 10 permit oneof the elements 6, 8, 10 to be disengaged from tissue while the othertwo elements 6, 8, 10 substantially maintain the shape of the previouslydisplaced tissue. In this manner, one of the elements 6, 8, 10, such asthe second element 8, may be disengaged, repositioned to engage stomachtissue and displaced again as shown in FIGS. 18 and 19. The displacedstomach tissue may also be held by the vacuum orifices 23 in the primaryshaft 16 (FIG. 1), the vacuum orifices 72 in the platform 14 (FIG. 5)and/or the tissue shaper 4 in addition to, or as a substitute for, thefirst and third tissue displacing elements 6, 10 which hold the tissuein a displaced state of FIG. 18. During displacement of stomach tissue,the elements 6, 8, 10 may displace the tissue by simply applying tensionto the wire 35 and/or moving them within the slots 44 (FIGS. 5 and 6).For example, the first tissue displacing element 6 may be retracteduntil the coil 32 is proximate to the platform 14 followed by movementwithin the slot 44 to change the angular orientation as describedherein.

Once the user has engaged tissue with each of the tissue displacingelements 6, 8, 10 and displaced each of the tissue displacing elements6, 8, 10 as desired, the user may simultaneously displace all of thetissue displacing elements 6, 8, 10 using the common retractor 12 (seeFIG. 21) to draw all three tissue displacing elements 6, 8, 10 into thetissue shaper 4 (see FIGS. 22 and 23). Suction may be applied to theorifices 72 in the platform 14 (FIG. 5) which may assist in drawing thetissue into the tissue shaper 4 as the common retractor 12 is moved intothe tissue shaper 4. Of course, the tissue displacing elements 6, 8, 10may be used to individually draw tissue into the tissue shaper 4, ratherthan using the common retractor 12 to simultaneously move all tissuedisplacing elements 6, 8, 10, without departing from the presentinvention. This may be accomplished by simply positioning the platform14 in the cavity or even distal to the shaper 4 so that tissue is drawninto the tissue shaper 4 by the tissue displacing elements 6, 8, 10alone (see FIG. 31).

Referring again to FIG. 8, the fold of tissue is shown contained withinthe tissue shaper 4. The fold of tissue forms the intersection betweenthe esophageal tract and the stomach and has an esophageal side 131 anda stomach side 133 although at least some of the tissue on theesophageal side 131 may be characterized as stomach tissue prior tocreation of the fold due to the disease state as described above. Thetissue shaper 4 is sized to hold the fold of tissue and may be adaptedto expand to a larger volume to accommodate the fold tissue due to theelastomeric portion 52 and the slits 60 (FIG. 4). Once the tissue iscontained within the tissue shaper 4, the fold may be manipulated as nowdescribed or any other manner described herein.

The fold of tissue in the shaper 4 may be manipulated using the tissueshifting element 110 as shown in FIGS. 8-10. The needle 112 and/orneedle 112A pierce one or both layers of the tissue fold and the wire114 is then pulled proximally thereby moving the needles 112 downward todraw more tissue into the tissue shaper 4 and shift tissue downwardwithin the shaper 4. The tissue shifting element 110 may also change aposition of the intersection between the stomach and the esophagealtract to increase a length of the esophageal tract. When only one tissuelayer is engaged as shown in FIG. 9, the tissue shifting element 110displaces only the stomach side 133 of the fold while the esophagealside 131 is held stationary by the vacuum orifices 23 on the primaryshaft 15 (see FIG. 1). The tissue may also be shifted within the tissueshaper 4 using the elements 6, 8, 10. In this manner, the tissuedisplacing elements 6, 8, 10 serve as tissue shifting elements inaccordance with the present invention. For example, the tissuedisplacing elements 6, 8, 10 may be used to displace the tissue furtherinto the cavity 50 or through the open distal end 65 of the tissueshaper 4 (see FIG. 31). The tissue displacing elements 6, 8, 10 may alsobe moved within the slots 44 to shift and displace tissue within thetissue shaper 4 in any manner described herein. The tissue displacingelements 6, 8, 10 may all be used to apply longitudinal displacement aswell as a change in angular position relative to the longitudinal axissimilar to use of the slots 44.

Methods of fastening the fold of tissue together and additional methodsof manipulating the tissue are now described. Each of the fasteningmethods may be used with any of the methods of manipulating tissue andforming the fold described herein. For the purpose of describing thesemethods, fasteners F1, F2, F3, F4, F5, F6, F7 are shown in FIGS. 24 and25. Fasteners F1, F2 are longitudinally aligned at one end of the tissuefold (formed near the end 24 of the tissue shaper 4) and F6, F7 are atthe other end of the tissue fold (and formed near the other end 26 ofthe tissue shaper 4). Fasteners F3-F5 are longitudinally aligned along acentral portion of the fold of tissue. Of course, more or fewerfasteners may be applied and any of the fastener appliers describedherein or any other suitable fastener applier may be used with orintegrated with the device 2. As mentioned above, the clamping elements61, 63 may be used to clamp the fold of tissue during application offasteners and all methods described herein may include application ofthe clamping elements 61, 63 during each fastening step. The clampingelements 61, 63 may be released if further tissue displacing steps arecarried out followed by application of the clamping elements 61, 63before applying another fastener.

In one aspect of the present invention, the fastener applier 90 of FIG.11 is used to deliver a plurality of fasteners, such as the staples 94,simultaneously. Once the fold of tissue is held in the desired shape, asshown in FIG. 23 for example, the fasteners F1, F2 may be appliedsimultaneously with the fastener applier 90 positioned at position P1 ofFIG. 6. Fasteners F3, F4, F5 are applied at position P2 and fastenersF6, F7 are applied at position P3. Three separate fastening appliers 90may be used to simultaneously apply each row of fasteners or onefastener applier 90 may be used to apply all of the fasteners in threeseparate steps using different preselected cartridges 92, 92A, 92B. Whenonly one fastener applier 90 is used, the fastener cartridge 92 may bechanged after each row of fasteners is applied. If the fastener applierhas enough fasteners, the fastener applier 90 is simply rotated withinthe window 80 to the next appropriate location and the next set offasteners 94 is applied. The fastener cartridge may be adapted todispense the necessary amount of fasteners 94 at each application.

The fasteners 1-7 may be applied after all tissue manipulations havebeen completed. Alternatively, some of the fasteners F1-F7 may beapplied and the tissue is further manipulated with the elements 6, 8, 10or shifting element 110 followed by application of more fasteners F1-F7.This process may be repeated until all of the fasteners F1-F7 areapplied while the user manipulates tissue between each fastening step asdesired. The vacuum orifices 23 in the shaft 15 or the vacuum orifices72 in the platform 14 may be used to further stabilize the fold oftissue between the fastening steps. The tissue shaper 4 itself may alsohelp to firmly hold the fold of tissue (particularly if the elastomericportion 52 is used) yet still permits shifting of tissue within thetissue shaper 4 and still permits tissue to be drawn into the tissueshaper 4. Various methods of manipulating tissue with the device 2 mayinclude holding selected parts of the tissue fold stationary whiletissue is manipulated with another part of the device 2. To this end,the vacuum orifices 23 in the shaft 15, the vacuum orifices 72 in thecommon retractor 23, the tissue displacing elements 6, 8, 10 and eventhe tissue shifting elements 110 may be used to hold parts of the tissuestationary while other parts of the device 2 are used to furtherdisplace the tissue in any manner described herein.

In one example of a procedure having a number of fastening and tissuemanipulation steps, fasteners 1, 2 and fasteners 6, 7 at the ends 24, 26of the tissue shaper 4 are applied first followed by application offasteners 3, 4, 5 along the central portion of the tissue shaper 4. Inthis manner, the tissue fold is created at the ends 24, 26 of the tissueshaper 4 first followed by formation of the central portion of the fold.Referring to FIGS. 26-28, the third tissue displacing elements 10 (andthe first tissue displacing element 6 in similar fashion on the oppositeside) extends outwardly to provide for longitudinal and an angulardisplacement upon retraction as described herein. The first and thirdtissue displacing elements 6, 10 may also be manipulated within theslots 44, such as toward the ends 24, 26 of the tissue shaper 4, asshown in FIGS. 27-28. In this manner, tissue has been drawn towards theends 24, 26 of the tissue shaper 4. The tissue is the drawn into theshaper 4 by moving the first and third displacing elements in any mannerdescribed herein to the dotted line position of FIG. 28. The fasteners1, 2 and 6, 7 may then be applied near the ends 24, 26 of the tissueshaper 4.

The second tissue displacing element 8 may then be used to engagestomach tissue in the central portion of the tissue shaper 4 as shown inFIG. 29. The tissue is then pulled down by the second tissue displacingelement 8 and fasteners 3, 4, 5 may then be applied simultaneously ormay be applied one at a time between manipulations of the second tissuedisplacing element 8. When moving the first and third tissue displacingelements 6, 10, the lock 75 may be used to lock the first and thirdtissue displacing elements together 6, 10 and simultaneously move thefirst and third tissue displacing elements 6, 10.

In another example of the present invention, fasteners 3, 4, 5 along themiddle of the tissue shaper 4 (and along the middle of the tissue foldbeing created) are applied first and tissue is then manipulated prior toapplication of fasteners 1,2 and 6, 7 at the ends 24, 26 of the tissueshaper 4. Tissue may be manipulated between fastening steps by engagingtissue with the first and third tissue displacing elements 6, 10 and/ortissue shifting element 110 to tighten or loosen the fold, to lengthenthe ends of the fold or to longitudinally stretch the fold as deemednecessary and as described herein. For example, the second tissuedisplacing element 8 is used to displace the central portion of thetissue fold downward and the first and third tissue displacing elements6, 10 may then be engaged with tissue as shown in FIG. 30. The first andthird tissue displacing elements 6, 10 are then retracted to pull tissuedownward and also to move tissue towards the ends of the tissue shaper4. To this end, the tissue displacing elements 6, 10 may impartdisplacements in any manner described herein. For example, the first andthird tissue displacing elements 6, 10 may pull tissue towards the ends24, 26 of the mold followed by displacement within the slots 4 towardthe ends 24, 26 in a manner similar to the displacements shown in FIGS.26-28 but in the opposite direction. In this manner, the tissue fold iscreated from the central portion towards the ends 24, 26 of the tissueshaper 4.

In yet another method of applying the fasteners F1-F7, the fastenerapplier may be held in a substantially stationary position and thetissue is manipulated after each fastener application. Referring againto FIGS. 22 and 23, an example of such a method is shown. Fastener F3 isapplied in the position of FIG. 22. The tissue is then pulled furtherinto the tissue shaper 4 using the tissue displacing elements 6, 8, 10(or the common retractor to displace all three tissue displacingelements 6, 8, 10 simultaneously) and fastener F4 is then appliedwithout moving the fastener applier from the position in which fastenerF3 was applied. In this manner, the fastener applier may stay in asingle, stationary position for several fastening steps while the tissueis manipulated between fastening steps. Fastener F5 may then be appliedafter further displacement of tissue to complete a row of fasteners nearthe central plane. Rather than completing the row of fasteners, the usermay rotate the fastener applier to apply fasteners F1 and/or F6.

Referring now to FIG. 31, the tissue may also be manipulated through theopen end 65 of the tissue shaper 4 and all methods described above maybe practiced in this manner. For example, the method of applying thefasteners F1-F7 just described may be useful when the fold of tissueextends through the open end 65 of the tissue shaper 4. The user mayclearly see how the formation of the fold is progressing as eachfastener F1-F7 is applied and the fold becomes exposed through the openend 65 of the tissue shaper 4. As such, all methods of manipulating andfastening tissue described herein shall be applicable to methods ofgathering and fastening tissue which partially extends through the openend 65 of the tissue shaper 4.

The present invention has been described with respect to the preferredembodiment, however, it is understood that numerous modifications couldbe made without departing from the scope of the present invention. Forexample, the tissue shaper 4 may be omitted or could be a user actuatedstructure without departing from the scope of the present invention.

1-82. (canceled)
 83. A medical device for forming an intersectionbetween the esophagus and the stomach, comprising: a shaft and aplurality of vacuum orifices on the shaft for grasping esophageal tissueand a tissue displacing element coupled to the shaft, the shaft defininga longitudinal axis; a tissue shaper coupled to the shaft and a tissueshifting element also coupled to the shaft, the tissue shaper having anopen end leading to a cavity that receives a fold of stomach tissuedisplaced by the tissue displacing element, the tissue shifting elementbeing configured to displace the fold of stomach tissue held by thetissue shaper; a flexible elongate element having a tissue engagingelement at a distal end of the tissue displacing element; a cavity forreceiving and forming the fold of stomach tissue; a plurality offasteners for insertion into the fold of stomach tissue; and a clampingelement associated with the cavity to hold the fold of stomach duringinsertion of the plurality of fasteners into the fold of stomach tissue.84. The medical device of claim 83, wherein the tissue shaper isremovably attached to the shaft.
 85. The medical device of claim 84,wherein the tissue shaper is removably attached to the shaft by asnap-fit connection.
 86. The medical device of claim 85, wherein thetissue shaper has substantially straight edges, forming an acute angle,symmetrically disposed about the longitudinal axis of the shaft.
 87. Themedical device of claim 83, wherein: a sheath slidably coupled to theflexible elongate element, the sheath being slidable to cover anduncover a distal portion of the flexible elongate element, wherein ashape of the distal portion changes when the sheath covers the distalportion of each of the flexible elongate elements compared to anuncovered shape.
 88. The medical device of claim 83, wherein: a fastenerapplier for inserting the plurality of fasteners to the fold of stomachtissue.
 89. The medical device of claim 88, wherein: a fastener lumen,the fastener applier being slidable within the fastener lumen todifferent longitudinal positions for insertion of the plurality offasteners.
 90. The medical device of claim 88, wherein: the fastenerlumen permitting reorientation of the fastener applier by at least 90degrees relative to the longitudinal axis of the shaft.
 91. The medicaldevice of claim 88, wherein: a fastener cartridge containing theplurality of fasteners.